Direct costs of bovine spongiform encephalopathy control measures in Germany.

On 26 November 2000, the first autochthonous case of bovine spongiform encephalopathy (BSE) was detected in Germany. Since then, a total of 413 BSE cases have been confirmed, resulting in the culling and destruction of 17 313 heads of cattle. In view of the possible risks for human and animal health, Germany has adopted EU regulations along with some additional requirements concerning active surveillance and response measures after detecting a BSE-positive animal. In this study, we used a stochastic model to estimate the costs incurred by the ensuing legislative amendments responding to BSE between November 2000 and December 2010. The total costs were estimated to range between 1847 and 2094 million Euros. They peaked in 2001 (about 394 million Euros) and declined since. About 54% of the costs (approximately 1000 million Euros) were incurred by the extension of the feed ban for animal protein to all farmed livestock. Active surveillance accounted for 21% (405 million Euros), the incineration of animal protein for 13% (249 million Euros) and the removal of specified risk material for 11% (225 million Euros). Only 1% of the costs was related to response measures after detecting a BSE-positive animal, including indemnity payments for culled cattle and confiscated carcasses at the slaughterhouse.

Initial experience and safety in the treatment of chronic total occlusions with fiberoptic guidance technology: optical coherent reflectometry.

Percutaneous treatment of chronic total coronary occlusions has been limited by procedural complications such as vessel injury or perforation. Optimizing visualization in the vessel with optical coherent reflectometry and a forward-looking fiberoptic guidance technology may improve the safety and efficacy of percutaneous treatment of these lesions.

Intracoronary autologous blood to seal a coronary perforation.

BACKGROUND: Coronary artery perforation is a rare but serious complication of percutaneous coronary interventions. CASE REPORT: We report on the treatment of a coronary perforation during percutaneous transluminal coronary angioplasty (PTCA) of the left anterior descending (LAD) coronary artery in a patient suffering from post infarction angina complicated by cardiogenic shock. The perforation was treated successfully with intracoronary administration of the patient's own blood. CONCLUSION: This new technique may be used as adjunctive therapy to prolonged balloon inflation, coronary stenting, coronary microcoil and gelfoam embolization in the treatment of severe and hemodynamically compromising perforations.

SMART: The microstent's ability to limit restenosis trial.

In this randomized, prospective, multicenter trial (n = 661) of patients with de novo or restenotic coronary lesions, 330 patients received the MicroStent(R) II (MSII), and 331 received the Palmaz-Schatz (PS) stent. The short-term procedural success rates were 94.4% and 95.7%, respectively (P = 0.47). The 30-day cumulative incidence of major adverse events [death, myocardial infarction, CVA, target lesion revascularization (TLR)] was 6.4% for the MSII and 4.5% for the PS stent (P = 0.31). The in-stent binary restenosis rate at 6 months was 25.2% for the MSII and 22.1% for the PS stent (P = 0.636). Using Kaplan-Meier estimates, the incidence of clinically driven TLR was 8.9% for the MSII and 9.2% for the PS stent at 180 days; at 270 days, it was 12.8% and 12.1%, respectively (P = 0.83). MSII and the PS stents were comparable with respect to short-term procedural success, complications, and late clinical and angiographic restenosis.

Chronic total occlusions: experience with fiber-optic guidance technology--optical coherence reflectometry.

Chronic total occlusions are difficult to treat and continue to challenge the interventional cardiologist. The primary difficulty is safely crossing the total occlusion with a guidewire before any revascularization can begin. One of the main reasons conventional and newer guidewires have not proven effective is simply the lack of visualization to safely steer the guidewire across the occlusion. This limitation can be overcome with new technology using a "forward-looking" fiber-optic guidance. The Safe-Steer TO (Total Occlusion) Crossing System is a new guidance system that uses optical coherence reflectometry to steer a guidewire through total occlusions. Optical coherence reflectometry uses algorithms to determine tissue types (plaque vs arterial wall) by measuring the intensity of the reflection of near-infrared light. The authors' clinical experience with the Safe-Steer System has met considerable success. With their initial 28 patients (7 women, 21 men) with known chronic total occlusions and confirmed ischemia, the primary success rate for the crossing the occlusion was 86% (24/28 cases). The average occluded lesion length was 41.1 +/- 30.8 mm. Our initial clinical experience demonstrates that the optical guidewire is a viable technology in the treatment of chronic total occlusions.

Peripheral vascular disease: perspectives on aortoiliac, renal, and femoral treatments using catheter-based techniques.

The percutaneous treatment of peripheral vascular disease has advanced over the past two decades and is fast becoming the preferred treatment of choice. Stents have positively altered the clinical outcomes in peripheral revascularizations. Anatomic variability is an important factor in determining if the patient is an ideal percutaneous interventional candidate. Future technological developments in percutaneous interventions will help include new patients with peripheral vascular disease previously considered nonideal percutaneous candidates.

Percutaneous transmyocardial laser revascularisation for severe angina: the PACIFIC randomised trial. Potential Class Improvement From Intramyocardial Channels.

BACKGROUND: Percutaneous transmyocardial laser revascularisation (PTMR) is a proposed catheter-based therapy for refractory angina pectoris when bypass surgery or angioplasty is not possible. We undertook a randomised trial to assess the safety and efficacy of this technique. METHODS: 221 patients with reversible ischaemia of Canadian Cardiovascular Society angina class III (61%) or IV (39%) and incomplete response to other therapies were recruited from 13 centres. Patients were randomly assigned PTMR with a holmium:YAG laser plus continued medical treatment (n=110) or continued medical treatment only (n=111). The primary endpoint was the exercise tolerance at 12 months. Analyses were by intention to treat. FINDINGS: 11 patients died and 19 withdrew; 92 PTMR-group and 99 medical-treatment-group patients completed the study. Exercise tolerance at 12 months had increased by a median of 89.0 s (IQR -15 to 183) with PTMR compared with 12.5 s (-67 to 125) with medical treatment only (p=0.008). On masked assessment, angina class was II or lower in 34.1% of PTMR patients compared with 13.0% of those medically treated. All indices of the Seattle angina questionnaire improved more with PTMR than with medical care only. By 12 months there had been eight deaths in the PTMR group and three in the medical treatment group, with similar survival in the two groups. INTERPRETATION: PTMR was associated with increased exercise tolerance time, low morbidity, lower angina scores assessed by masked reviewers, and improved quality of life. Although there is controversy about the mechanism of action, and the contribution of the placebo effect cannot be quantified, this unmasked study suggests that this palliative procedure provides some clinical benefits in the defined population of patients.

A retrospective study of 6,671 patients comparing coronary stenting and balloon angioplasty.

OBJECTIVE: To determine whether coronary stenting, compared to percutaneous transluminal coronary angioplasty, reduces the incidence of five clinical endpoints during a six-month follow-up period. BACKGROUND: There is considerable debate concerning whether coronary stents improve clinical outcomes, especially given the rapid growth in the use of coronary stents and their economic impact. METHODS: Study population included a total of 6,671 consecutive patients at 32 hospitals in 16 different states who underwent single or multi-vessel revascularization during 1997. Patients were divided into one of two groups: those who only underwent standard balloon angioplasty (PTCA) for all treated vessels and those who received coronary stents (STENT) in all treated vessels. RESULTS: STENT patients were significantly less likely to have emergency coronary artery bypass surgery (CABG) (p = 0.001) or die during initial procedure (p = 0.034) but were more likely than PTCA patients to be treated for hematoma (p = 0.002) and bradycardia (p = 0.004). After accounting for difference in patient characteristics, risk factors, procedure complications, and number of devices utilized, the estimated odds-ratio indicates that coronary stenting, compared to PTCA, significantly (p < 0.05) reduced adverse outcomes for only one clinical event, myocardial infarction. CONCLUSIONS: Compared to balloon angioplasty patients, coronary stent patients have no statistically significant differences in regard to additional percutaneous coronary intervention or coronary artery bypass during a six-month follow-up period. Since direct cardiac catheterization lab costs associated with coronary stenting is nearly 2.5 times greater than standard balloon angioplasty, our results suggest the cost-effectiveness of coronary stenting, especially for "hard" clinical outcomes, needs to be established.

Low- versus high-dose recombinant urokinase for the treatment of chronic saphenous vein graft occlusion.

Recanalization of a totally occluded saphenous vein graft (SVG) using commercially available urokinase from human kidney cells has been shown to be effective, but the duration of infusion and complications such as allergic reactions, bleeding events, and non-Q-wave myocardial infarction have limited its acceptance. Recently, genetic engineering has allowed the synthesis of recombinant urokinase (r-UK). Patients with an occluded SVG from 37 centers were randomized to receive a 6-hour infusion of either low-dose (125,000 IU/hour) or high-dose (350,000 IU/hour) r-UK followed by up to a maximum of 18 hours of r-UK (125,000 IU/hour) via a subselective catheter directly into the occluded vein graft. The primary study end point was final preintervention achievement of Thrombolysis In Myocardial Infarction (TIMI) flow > or = 2 using core angiographic analysis. One hundred seven patients were randomized and 98 received the study drug (low dose 52 patients, high dose 46 patients). TIMI flow > or = 2 after completion of the study drug was higher in the high-dose group (51% vs 24%, p = 0.019). This difference narrowed, but a trend was still evident on the final angiogram after adjunctive mechanical intervention (72% vs 58%, p = 0.254). Bleeding complications were frequent; severe or life-threatening bleeding occurred in 12% of patients on the low dose and 11% of patients on the high dose (p = NS), including 2 intracerebral bleeds, both of which were fatal with 1 in each group. Thus, in patients with an occluded SVG, a randomized trial of direct low-dose versus high-dose r-UK infusion demonstrated increased recanalization rates (TIMI flow > or = 2) in the high-dose arm. Percutaneous revascularization of SVG with r-UK can be accomplished with acceptable success rates, but complications are frequent.

Obliteration of a coronary artery aneurysm with a PTFE-covered stent: endoluminal graft for coronary disease revisited.

This is the first reported use of the JOSTENT stent graft for aneurysm disease in native coronaries. Consideration can be given to using this polytetrafluoroethylene (PTFE)-covered stent in situations such as dissections and restenosis in saphenous vein grafts or in long native coronary arteries without side branches, though further investigation is warranted.